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Investigation of a Digital Healthy Habits Program for Individuals With Breast Cancer

Investigation of a Digital Healthy Habits Program for Individuals With Breast Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04967209
Enrollment
30
Registered
2021-07-19
Start date
2021-07-05
Completion date
2021-08-12
Last updated
2023-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Cancer, Obesity, Overweight, Overweight and Obesity

Brief summary

This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app (features they liked and didn't like), the extent to which they believe the app would have to be further adapted, how they would feel about such an app being embedded in their cancer care and when in their care pathway they would like to be offered it.

Detailed description

This mixed methods study will involve obtaining user feedback on the first 4 weeks of the Healthy Habits for Cancer (HCC) Program. Participants will be recruited and asked to try the HCC app for 4 weeks. Short pre and post surveys and in-depth qualitative interviews will be conducted exploring their views on the app, the extent to which they believe the app would have to be further adapted, how they would feel about such an app being embedded in their cancer care and when in their care pathway they would like to be offered it.

Interventions

None listed

Sponsors

Noom Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Able to understand and provide informed consent * 18 years and older * Female * \> 6 months postpartum * Not currently pregnant or planning to become pregnant in the next 5 months * Diagnosed with stage I-IV breast cancer \< 5 years ago: * Completed active breast cancer treatment (e.g., chemotherapy, radiation, surgery) 1 month to 5 years ago, with the exception of hormonal/endocrine therapy * Currently prescribed hormone therapy (e.g. Tamoxifen) as a breast cancer treatment * Not diagnosed with an eating disorder * Healthy weight, overweight, or obesity (BMI ≥ 18.5) * Willingness to use the program over the course of the 4 weeks in order to enable them to provide feedback on its features * Own a smartphone with iOS operating system (i.e., Apple iPhone)

Exclusion criteria

* Inability or unwillingness of a participant to give written informed consent * Underweight (BMI \< 18.5) * Currently pregnant or \<6 months postpartum * Presence of a diagnosed physical or mental health condition or abnormality that impacts the ability to participate in a program that involves asking participants to monitor diet, physical activity, or weight (e.g., eating disorder, bipolar disorder). If there is any doubt at initial screening the investigator will recommend that the patient receives sign off from their clinical team. * Currently undergoing IV chemotherapy or radiation * Plans for surgery in the next 6 weeks * Currently diagnosed or being treated for a second primary cancer (i.e. cancer of another organ, not due to breast cancer metastasis), with the exception of non-melanoma skin cancers (e.g. basal cell carcinoma)

Design outcomes

Primary

MeasureTime frameDescription
Functional Assessment of Cancer Therapy - Breast quality-of-life instrument4 weeksSelf reported measure of multidimensional quality of life (QL) in patients with breast cancer.
Qualitative interviews4 weeksData analyses will content analyze key themes in participants' experiences using the program, including their likes and dislikes for the program.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026